Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Principles of method if other than guideline:
according to H.F. Smyth et al., Am. Ind. Hyg. Ass. J. 23, 95 - 107 (1962)
GLP compliance:
no
Test type:
other: inhalation hazard test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
Young adult laboratory rats were purchased from a breeder.

Administration / exposure

Route of administration:
inhalation: vapour
Details on inhalation exposure:
200 L air/ h were run through a 5 cm thick layer of the test substance. The atmosphere temperature was 20 °C. The atmosphere was saturated with vapour .
Remarks on duration:
10 min, 30 min, 1 h, 3 h, 7 h
Concentrations:
10 min: 4.5 mg/L = 998 ppm
30 min: 2.1 mg/L = 445 ppm
1 h: 2.15 mg/L = 477 ppm
3 h: 1.08 mg/L = 259 ppm
7h: 1 mg/L = 222 ppm
No. of animals per sex per dose:
10 min, 30 min and 60 min exposures: 12 (each 3 male and female)
3 h and 7 h exposures: 6 (each 3 male and female)
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC100
Effect level:
ca. 0.81 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.54 mg/L air
Exp. duration:
4 h
Remarks on result:
other: calculated from 1h exposure
Mortality:
10 min exposure: 0/12
30 min and 60 min exposure: 1/12
3 h and 7 h exposure: 6/6
Clinical signs:
other: Attempts to escape, accelerated respiration, intermittently breathing, reddish nasal secretion, snout wiping, crouched position, ruffled fur, apathy, unsteady - restlessly - staggering - trembling gait
Gross pathology:
Animals that died: heart: acute dilatation; acute congestive hyperemia; lung: slight enhanced blood content; liver: partly slight brightened; kidneys: whitish top of the papilla.
Sacrificed animals: partly white-yellowish papilla.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information
Conclusions:
The test substance was shown to be toxic via inhalation to rats. LC50 is calculated to be 0,5375
Executive summary:

Rats were exposed to the vapour of the test substance. After 10 min of exposure no death was observed. After 30 min and 1 h 1/12 animals died while after 3 and 7 h of exposure 6/6 animals were dead. The experimental set up did not allow to calculate a LD50 but showed that prolonged inhalation of a saturated atmosphere (vapour) led time-dependently to increased mortality.